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To Assess Immunogenicity of Coronavirus Disease 2019 (COVID-19) Vaccine in Cancer Patients Receiving Cancer Treatment (CANINE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04821570
Recruitment Status : Recruiting
First Posted : March 29, 2021
Last Update Posted : March 29, 2021
Sponsor:
Information provided by (Responsible Party):
University of Kansas Medical Center

Brief Summary:
This is a trial of prospective collection of serial blood samples after administration of COVID-19 vaccine in patients with cancer who are receiving active cancer treatment, planned to start therapy with 14 days of consent, or have had stem cell transplant. Cancer treatments and administration of vaccine are not controlled by the study.

Condition or disease Intervention/treatment
Breast Cancer Lung Cancer Melanoma (Skin) Biological: COVID-19 Vaccine

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cancer Therapy and Immunogenicity of COVID Vaccine (CANINE Trial)
Actual Study Start Date : February 23, 2021
Estimated Primary Completion Date : March 28, 2022
Estimated Study Completion Date : March 28, 2023


Group/Cohort Intervention/treatment
Chemotherapy (IV and oral) Biological: COVID-19 Vaccine
Per recommended dosing schedule

Immunotherapy Biological: COVID-19 Vaccine
Per recommended dosing schedule

Chemotherapy + Immunotherapy Biological: COVID-19 Vaccine
Per recommended dosing schedule

Cyclin- dependent kinase (CDK) 4/6 inhibitors Biological: COVID-19 Vaccine
Per recommended dosing schedule

Stem Cell Transplant recipients Biological: COVID-19 Vaccine
Per recommended dosing schedule




Primary Outcome Measures :
  1. Geometric mean titer (GMT) with corresponding 95%confidence interval (CI) at each time point of the entire population and individually of all cohorts [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201. ]
    Elecsys Anti severe acute respiratory syndrome (SARS) coronavirus 2 (CoV 2) S quantitative assay

  2. Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  3. Geometric mean titer (GMT) with corresponding 95% CI at each time point of the entire population and individually of all cohorts [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  4. Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  5. Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  6. Geometric mean fold rise (GMFR) with corresponding 95% CI at each post-baseline timepoint over preinjection baseline [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 S quantitative assay


Secondary Outcome Measures :
  1. Geometric median, minimum and maximum assay titer values for each cohort [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  2. Geometric median, minimum and maximum assay titer values for each cohort [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  3. Geometric median, minimum and maximum assay titer values for each cohort [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 S quantitative assay

  4. The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  5. The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  6. The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  7. The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  8. The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  9. The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Moderna: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  10. The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  11. The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  12. The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  13. The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  14. The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  15. The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Pfizer: Baseline, Day 21, Day 51, Day 111, Day 201 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  16. The number of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  17. The percentage of subjects with fold-rise ≥ 2 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  18. The number of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  19. The percentage of subjects with fold-rise ≥ 3 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  20. The number of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay

  21. The percentage of subjects with fold-rise ≥ 4 from baseline at each post injection time points with 95% CIs [ Time Frame: Participants will have scheduled blood sampling (for immunogenicity assessment) at: For Johnson & Johnson: Baseline, Day 29, Day 57, Day 119, Day 209 ]
    Elecsys Anti SARS CoV 2 quantitative assay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Participants undergoing treatment for breast cancer, lung cancer and melanoma with chemotherapy, immunotherapy and/or oral anticancer agents, or have undergone stem cell transplantation
Criteria

Inclusion Criteria:

  • Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
  • Males and females age ≥ 18 years
  • Patients with breast cancer, lung cancer, malignant melanoma or who have undergone stem cell transplant or chimeric antigen receptor (CAR) T cell therapy for a hematologic malignancy.

Other cancer types including hematologic malignancies may be allowed if they are receiving treatments outlined in section 4.1.4

  • Solid Tumor patients and those with hematologic malignancies: Currently receiving active anti-cancer therapy, or planned to start within 14 days, with intravenous cytotoxic chemotherapy (oral or intravenous), intravenous chemoimmunotherapy combination, immunotherapy alone, an oral CDK 4/6 inhibitor. (This does not apply to recipients of stem cell transplant and CAR T therapy)
  • Therapy may be neo/adjuvant or for metastatic disease
  • Eastern Cooperation Oncology Group (ECOG) Performance status (PS) of 0-2

Exclusion Criteria:

* Life expectancy of < 12 months


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04821570


Contacts
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Contact: KUCC Navigation 9135883671 kucc_navigation@kumc.edu

Locations
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United States, Kansas
The University of Kansas Cancer Center, Westwood Campus Recruiting
Kansas City, Kansas, United States, 66205
Contact: KUCC Navigation    913-588-3671    kucc_navigation@kumc.edu   
Sponsors and Collaborators
University of Kansas Medical Center
Investigators
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Principal Investigator: Qamar Khan, MD University of Kansas
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Responsible Party: University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT04821570    
Other Study ID Numbers: IIT-2021-CANINE
First Posted: March 29, 2021    Key Record Dates
Last Update Posted: March 29, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas